Second Edition FACT Common Standards for Cellular Therapies [Print Version]

Description:

The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. In early stage product development and early phase clinical trials, these Standards provide the quality management infrastructure to facilitate patient and data accrual to advance the therapy. Ideally, disease, discipline, or product-specific standards will be added in the future through collaboration with experts in those specialties where clinical teams and products are ready for additional standardization and voluntary accreditation.